MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. XPS® BLADE; BUR, EAR, NOSE AND THROAT

Model Number 1884002HRE

Device Problems Break (1069); Complete Blockage (1094)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2017

Event Type  malfunction  

Manufacturer Narrative

No product analysis; device not returned for evaluation.If information is provided in the future, a supplemental report will be issued.

Event Description

A medwatch report ref.Mw5074243 was received from the fda's medwatch program.The unknown contact / site reported that the blade appeared to be clogged; then it broke in half.No adverse event was reported.

• Brand Name: XPS® BLADE
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: angie demo ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328355
• MDR Report Key: 7268308
• MDR Text Key: 100250105
• Report Number: 3004209178-2018-03246
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/11/2021
• Device Model Number: 1884002HRE
• Device Catalogue Number: 1884002HRE
• Device Lot Number: HG205H5
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/18/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/11/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1